FDA.report

IPS

Primary DI
00888118136121
Brand
IPS
Company
KLS-Martin L.P.
Model
60-500-17-09
Device description
SPLINT, SUPPLEMENTAL, EGUARD BLUE
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JEYPLATE, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118136121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118136121008881181361218881181361210888118136121

GMDN Terms

TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags

DUNS number
826499238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00888118143266PURE PECTUS24-070-40-092026-03-23
00888118143273PURE PECTUS24-070-42-092026-03-23
00888118143280PURE PECTUS24-070-44-092026-03-23
00888118143297PURE PECTUS24-070-46-092026-03-23
00888118143303PURE PECTUS24-070-48-092026-03-23
00888118143310PURE PECTUS24-070-50-092026-03-23
00888118143327PURE PECTUS24-071-40-092026-03-23
00888118143334PURE PECTUS24-071-42-092026-03-23
00888118143341PURE PECTUS24-071-44-092026-03-23
00888118143358PURE PECTUS24-071-46-092026-03-23
00888118143365PURE PECTUS24-071-48-092026-03-23
00888118143372PURE PECTUS24-071-50-092026-03-23
00888118145321PURE PECTUS24-070-50-892026-03-23
00888118145338PURE PECTUS24-071-50-892026-03-23
00888118149671LEVEL ONE CMF, STERILE25-882-06-712026-03-23
00888118149701LEVEL ONE CMF, STERILE25-883-17-712026-03-23
00888118149718LEVEL ONE CMF, STERILE25-883-19-712026-03-23
00888118149725LEVEL ONE CMF, STERILE25-887-17-712026-03-23
00888118149732LEVEL ONE CMF, STERILE25-887-19-712026-03-23
00888118149749LEVEL ONE CMF, STERILE25-889-09-712026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149701LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149718LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149725LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149732LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149749LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149756LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149763LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149770LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149787LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149794LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149800LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149817LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149824LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149831LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149848LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149855LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149879LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149886LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149893LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149909LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149916LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149923LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149930LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149947LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149954LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149961LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149978LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149985LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118153128LEVEL ONE NEURO, STERILEKLS-Martin L.P.JEY2026-03-23